MODIFICATION TO ELECSYS FSH II CALSET

Calibrator, Secondary

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Elecsys Fsh Ii Calset.

Pre-market Notification Details

Device IDK012399
510k NumberK012399
Device Name:MODIFICATION TO ELECSYS FSH II CALSET
ClassificationCalibrator, Secondary
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
ContactSherri L Coenen
CorrespondentSherri L Coenen
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-27
Decision Date2001-08-24
Summary:summary

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